Registration Dossier
Registration Dossier
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EC number: 947-945-3 | CAS number: -
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Letter From Monsanto Co To Usepa Regarding Toxicity Studies Of Dodecyl Phenol, With Attachments And Dated 5/22/96
- Author:
- Monsanto lab
- Year:
- 1 987
- Bibliographic source:
- OTS0532404
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- The teratology study of Dodecyl-Phenol
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Dodecylphenol
- EC Number:
- 248-312-8
- EC Name:
- Dodecylphenol
- Cas Number:
- 27193-86-8
- IUPAC Name:
- 2-dodecylphenol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- corn oil
- Details on exposure:
- Dodecylphenol was diluted in corn oil and given by qavage to five groups of five mated female Sprague-Dawley rat. at dosage. of 125 ,250,500, 1000, and 2000 mg/kq/day on days 6-15 of gestation.
- Duration of treatment / exposure:
- 10 days(days 6-15 of gestation)
- Frequency of treatment:
- twice daily
- Duration of test:
- 20 days
- No. of animals per sex per dose:
- 25
- Control animals:
- not specified
Examinations
- Maternal examinations:
- -Rats were observed twice daily for mortality and signs of toxicity on days 6 through 15 of gestation. -Necropsy and uterine examinations were performed on all surviving females on gestation day 20.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yesDetails on maternal toxic effects:-Mean maternal body weight gain was reduced in the 500 mq/kg/day group during the treatment period.-Mean food consumptl0n Was reduced durlng the day 6-10 lnterval in the 125, 250 and 500 mg/kg/day groups.-One female each in the 500 and 1000 mg/kg/day groups had resorption of all uterine implants.-No malformations were found by external examinatlon of fetuses.-No fetuses were available for examination in the 1000 and 2000 mg/kq/day dose groups because of maternal deaths.
Effect levels (maternal animals)
- Based on:
- not specified
- Remarks on result:
- other: not specified
Maternal abnormalities
- Abnormalities:
- not specified
- Description (incidence and severity):
- not specified
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: fetotoxicity
- Remarks on result:
- other: not specified
Fetal abnormalities
- Abnormalities:
- not specified
- Description (incidence and severity):
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
- Treatment related:
- not specified
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEL (no observed adversed effects level ) value of Dodecylphenol in Sprague-Dawley rats was observed at a dose of 500 mg/kg/day.
- Executive summary:
There was some evidence of maternal toxiclty at the 125 mg/kg/day dose level. and hlgher levels all caused greater degrees of response. There was no evidence of fetotoxicity based on the results of this study, dose levels of 20, 100 and 500 mg/kg/day were chosen for the full teratology study.thus based on resutls i-Mean maternal body weight gain was reduced in the 500 mq/kg/day group during the treatment period.Mean food consumption Was reduced durlng the day 6-10 lnterval in the 125, 250 and 500 mg/kg/day groups.One female each in the 500 and 1000 mg/kg/day groups had resorption of all uterine implants.No malformations were found by external examinatlon of fetuses.
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